Determination of related impurities in glimepiride tablets by the HPLC method

N. O. Savina, N. M. Ocherethyana, V. M. Britsun, N. V. Ostanina

Abstract

Glimepiride is one of the modern and effective drugs that counteract diabetes mellitus type 2. Like other drugs glimepiride must comply with quality standards set by relevant government departments.

Aim. To determine the content of related impurities in glimepiride tablets in order to assess the drug quality.

Materials and methods. The study was performed by the reversed-phase HPLC with a spectrophotometric detector in the isocratic mode, in the UV-region of the spectrum. To determine impurities the method of comparison with the solution having the known concentration of impurities and the active substance was used.

Results and discussion. It has been shown that the drug contains ≤ 0.18 % of identified and unidentified impurities.

Conclusions. The purity of the drug complies with the requirements of normative documents.